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    DRUG:

    casdatifan (AB521)

    i
    Other names: AB521
    Associations

    News

    Trials
    Company:
    Arcus Biosci, Otsuka
    Drug class:
    HIF-2α inhibitor
    Related drugs:
    Associations

    News

    Trials
    7d
    ARC-20: A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P1, N=362, Recruiting, Arcus Biosciences, Inc. | Trial completion date: Jul 2027 --> Mar 2029 | Trial primary completion date: Jul 2027 --> Mar 2029
    Trial completion date • Trial primary completion date
    |
    Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • Yutuo (zimberelimab) • casdatifan (AB521)
    18d
    PEAK-1: Randomized Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma (2024-515023-11-00)
    P2/3, N=308, Recruiting, Arcus Biosciences Inc.
    New P2/3 trial
    |
    Cabometyx (cabozantinib tablet) • casdatifan (AB521)
    26d
    Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC (clinicaltrials.gov)
    P2, N=32, Not yet recruiting, Dana-Farber Cancer Institute
    New P2 trial
    |
    Yutuo (zimberelimab) • casdatifan (AB521)
    4ms
    eVOLVE-RCC02: A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC (clinicaltrials.gov)
    P3, N=1116, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • volrustomig (MEDI5752) • casdatifan (AB521)
    4ms
    Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29) (clinicaltrials.gov)
    P1, N=14, Completed, Arcus Biosciences, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    itraconazole • casdatifan (AB521)
    5ms
    Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P3, N=720, Recruiting, Arcus Biosciences, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Cabometyx (cabozantinib tablet) • casdatifan (AB521)
    6ms
    Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29) (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, Arcus Biosciences, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    itraconazole • casdatifan (AB521)
    6ms
    eVOLVE-RCC02: A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC (clinicaltrials.gov)
    P3, N=1116, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • volrustomig (MEDI5752) • casdatifan (AB521)
    7ms
    Pharmacokinetics, pharmacodynamics and safety of casdatifan, a novel hypoxia-inducible factor-2α inhibitor, in healthy participants. (PubMed, Br J Clin Pharmacol)
    Casdatifan, after single and multiple dosing in healthy participants, was safe and tolerable. Linear PK was associated with a mean maximum erythropoietin reduction of 85% following a single dose and multiple doses of casdatifan, demonstrating a promising exposure-biological activity profile.
    PK/PD data • Journal
    |
    EPAS1 (Endothelial PAS domain protein 1) • CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    casdatifan (AB521) • midazolam hydrochloride
    8ms
    Hypoxia Inducible Factor-2α (HIF-2α) Pathway Inhibitors. (PubMed, J Kidney Cancer VHL)
    We discuss the major key inhibitors, with focus on belzutifan and review the various trials investigating its efficacy in monotherapy as well as in combination therapies in RCC...We also highlight emerging HIF-2α inhibitors currently in clinical trials, namely casdatifan, NKT-2152, and DFF332. Finally, we address the major toxicities and management of these inhibitors.
    Review • Journal
    |
    VHL (von Hippel-Lindau tumor suppressor) • EPAS1 (Endothelial PAS domain protein 1) • CA9 (Carbonic anhydrase 9) • POU5F1 (POU Class 5 Homeobox 1) • ARNT (Aryl Hydrocarbon Receptor Nuclear Translocator)
    |
    Welireg (belzutifan) • DFF332 • casdatifan (AB521) • imdatifan (NKT2152)
    9ms
    Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009) (clinicaltrials.gov)
    P1, N=25, Terminated, Exelixis | Phase classification: P1/2 --> P1 | Trial completion date: Jan 2027 --> May 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2026 --> May 2025; The study was terminated prior to starting the Phase 2 portion due to a business decision.
    Phase classification • Trial completion date • Trial termination • Trial primary completion date
    |
    Opdivo (nivolumab) • casdatifan (AB521) • zanzalintinib (XL092)
    9ms
    Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P3, N=720, Not yet recruiting, Arcus Biosciences, Inc.
    New P3 trial
    |
    Cabometyx (cabozantinib tablet) • casdatifan (AB521)